The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Diapex.
| Device ID | K033585 |
| 510k Number | K033585 |
| Device Name: | DIAPEX |
| Classification | Resin, Root Canal Filling |
| Applicant | BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
| Contact | Benjamin Lichtenwalner |
| Correspondent | Benjamin Lichtenwalner BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-13 |
| Decision Date | 2004-01-16 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DIAPEX 78325011 3107596 Live/Registered |
DiaDent Group International Inc. 2003-11-07 |
![]() DIAPEX 76540164 not registered Dead/Abandoned |
Gordon Tang Company, Inc. 2003-08-11 |